UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054936 |
|---|---|
| Receipt number | R000062589 |
| Scientific Title | Effects of Rocker Function during Gait on Ankle and Knee Joint Motion |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2025/01/10 09:37:08 |
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Basic information
Public title
Effects of Rocker Function during Gait on Ankle and Knee Joint Motion
Acronym
Effects of Rocker Function during Gait on Ankle and Knee Joint Motion
Scientific Title
Effects of Rocker Function during Gait on Ankle and Knee Joint Motion
Scientific Title:Acronym
Effects of Rocker Function during Gait on Ankle and Knee Joint Motion
Region
| Japan |
Condition
Condition
Stroke hemiplegia admitted to the rehabilitation department
Healthy Adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been reported that the foot rocker function contributes to efficient propulsion during walking, and obtaining efficient propulsion is thought to be one of the factors that expand the range of activity.
In order to devise a simple method for evaluating foot rocker function, we investigated the effects of each foot rocker functions on forward movement of the knee joint and ankle joint during walking.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic indices (time and distance factors, locus of motion, joint angles) during gait calculated using a three-dimensional motion analyzer (Kinema Tracer)
Key secondary outcomes
Basic information (age, sex, height, weight, diagnosis, date of onset, length of hospitalization, complications, history),
functional capacity information (posture and movement characteristics during walking, walking speed)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Markers for measurement are affixed to body of subjects.
The trajectory of body joints during walking on the treadmill is measured using a three-dimensional motion analyzer.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Consent to participate in this study
2. Stroke patients were admitted to Fujita Medical School Hospital on or after July 20, 2022.
3. The subjects are capable of treadmill walking at a watchful waiting level.
4. The subjects are able to perform it according to the instructions.
Key exclusion criteria
1. Healthy adults who have a history of stroke, neuromuscular disease, or cardiac disease.
2. Those who cannot perform voluntary movements due to unstable general condition or impaired consciousness.
3. Those who have difficulty understanding instructions.
4. Pregnant women and women who may become pregnant.
5. Those who are judged to be inappropriate by the researcher.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2000
r13aeri@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Risako |
| Middle name | |
| Last name | Katada |
Organization
Fujita Health University Haneda Clinic
Division name
Rehabilitation Complex
Zip code
114-0041
Address
HANEDA INNOVATION CITY Zone A, 1-1-4, Hanedakuko, Ota-ku, Tokyo, Japan
TEL
03-5708-7850
Homepage URL
r13aeri@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062589
